Analysis of the post-marketing commitment and submissions of data from a 10-year epidemiology study on the use of pioglitazone shows that there is no statistically significantly increased risk of bladder cancer among patients ever exposed to this agent. This study was conducted to investigate whether patients with type 2 diabetes who were exposed to pioglitazone were at an increased risk of bladder cancer, and was required by different international regulatory authorities.

The primary analysis of the 10-year findings found no association between the use of pioglitazone and the risk of bladder cancer. Additionally, no association was found between the risk of bladder cancer and the duration of pioglitazone use, increased cumulative dose of pioglitazone or the time since initiating pioglitazone.

In the five-year interim analysis published in Diabetes Care, a statistically significant increased risk among patients with type 2 diabetes who used pioglitazone for two or more years was observed. However, the 10-year final analysis did not show any statistically significant findings of increased risk of bladder cancer with long term use of pioglitazone. The data will be shared with additional regulatory authorities in accordance with local requirements around the world, and final results will be submitted for publication in 2014.  

Source:
Takeda press release August 28 2014